FDA 510(k) Application Details - K163339

Device Classification Name	Probe, Blood-Flow, Extravascular   More FDA Info for this Device
510(K) Number	K163339
Device Name	Probe, Blood-Flow, Extravascular
Applicant	SPECTRALMD, INC. 2515 MCKINNEY AVENUE DALLAS, TX 75201 US Other 510(k) Applications for this Company
Contact	J. MICHAEL DIMAIO Other 510(k) Applications for this Contact
Regulation Number	870.2120   More FDA Info for this Regulation Number
Classification Product Code	DPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2016
Decision Date	08/17/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review